health-systems PRODUCT news

Fragmin(dalteparin sodiuminjection)

Eisai Inc (Woodcliff Lake,NJ) recently received FDAapproval for a new indicationfor Fragmin. The newindication is for the extendedtreatment of symptomaticvenous thromboembolism(VTE; proximal deepvein thrombosis [DVT]and/or pulmonary embolism[PE]) to reduce therecurrence of VTE in patientswith cancer. Patientswith cancer have an increasedrisk of VTE, compared with thosewithout cancer and thus VTE is a frequentmedical complication for patientswith cancer. Additionally, patients withcancer may be immobilized, predisposingthem to this condition. Fragmin alsois indicated for the prevention of DVT,which may lead to PE, in patients undergoinghip replacement surgery, in at-riskpatients undergoing abdominal surgery,and in at-risk acutely ill patients whosemobility is severely restricted. In addition,Fragmin is approved for the prophylaxisof ischemic complications resultingfrom unstable angina and non?Q-wavemyocardial infarction, when concurrentlyadministered with aspirin therapy. Theproduct is administered by subcutaneousinjection. It must not be administeredby intramuscular injection. Formore information, visit www.fragmin.com,or call 800-272-8804.

Privigen [ImmuneGlobulin Intravenous(Human), 10% Liquid]

CSL Behring (King of Prussia, Pa)recently received FDA approval to marketPrivigen, an intravenous immunoglobulin(IVIg) for treating patients diagnosedwith primary immunodeficiency.Privigen also is indicated for the treatmentof chronic immune thrombocytopenicpurpura to rapidly raise plateletcounts to prevent bleeding. A 10%liquid preparation of polyvalent humanimmunoglobulin, Privigen offers healthcare professionals convenience andease of use. The product is the first andonly proline-stabilized IVIg that isalways ready for immediate use,requiring no refrigeration or reconstitution.For additional information, visitwww.CSLBehring.com.

Supprelin LA (histrelinacetate)

Indevus Pharmaceuticals Inc(Lexington, Mass) recently announcedthe availability of Supprelin LA subcutaneousimplant, 50 mg, for the treatmentof children with central precociouspuberty (CCP). Children with CCP(neurogenic or idiopathic) have anearly onset of secondary sexual characteristics(earlier than 8 years of agein girls and 9 years of age in boys).These children also show a significantlyadvanced bone age that can result indiminished height attainment. The recommendeddose of Supprelin LA is 1implant every 12 months. Each implantcontains 50 mg of histrelin acetate. Theimplant is inserted subcutaneously inthe inner aspect of the upper arm andprovides continuous release of histrelinacetate (65 ?g per day) for 12months of hormonal therapy. At thetime an implant is removed, anotherimplant may be inserted to continuetherapy. For more information, visitwww.supprelinla.com, or call 888-282-5372.

Thrombi-Pad

King Pharmaceuticals Inc (Bristol,Tenn) recently introduced Thrombi-Pad(3x3 Hemostatic Pad). Each Thrombi-Pad is a lyophilized pad containingthrombin, sodium carboxylmethylcellulose,and calcium chloride in a nonwovengauze. The product is applied topicallyand is indicated as a traumadressing for temporary control of moderate-to-severe bleeding wounds andfor the control of surface bleeding fromvascular access sites and percutaneouscatheters and tubes. Thrombi-Pad offers health care professionals inthe emergency room a new option toachieve active hemostasis at bleedingsites where they would typically usetrauma dressing. The product is easilyaccessible and requires no specialstorage, preparation, or assembly. Foradditional information, visit www.thrombi-pad.com.

Caffeine Citrate Injection

Abraxis Pharmaceutical Products (Schaumburg, Ill)recently received FDA approval for its abbreviated new drugapplication for Caffeine Citrate Injection, USP, 20 mg/mL.The product is the generic equivalent of Cafcit Injection(Mead Johnson and Co). Caffeine Citrate Injection is indicatedfor the short-term treatment of apnea of prematurity(AOP) in infants between 28 and <33 weeks gestational age.AOP is a condition in which cessation of breathing inpreterm infants can cause dangerously low levels of bloodoxygen. The product is available in 60-mg/3-mL single-usevials. For more information, visit www.appdrugs.com, or call800-551-7176.

Torisel (temsirolimus)

Wyeth Pharmaceuticals (Collegeville, Pa), a division ofWyeth, recently received FDA approval for Torisel. The productis a kinase inhibitor indicated for the treatment ofadvanced renal cell carcinoma. Torisel is the first targetedrenal cancer therapy proven to extend median overall survivalversus interferon-alpha, an active comparator, in thispatient population. The recommended dose of Torisel is 25mg infused over a 30- to 60-minute period once a week.Treatment should continue until disease progression orunacceptable toxicity occurs. The product is supplied as akit consisting of Torisel injection 25 mg/mL. The Torisel vialincludes an overfill of 0.2 mL. The kit also contains diluentfor Torisel. The diluent vial includes a deliverable volume of1.8 mL. For more information, visit www.wyeth.com.